EP4556068A3 - Oral inhalierte und nasale benzodiazepine - Google Patents

Oral inhalierte und nasale benzodiazepine

Info

Publication number
EP4556068A3
EP4556068A3 EP25169181.2A EP25169181A EP4556068A3 EP 4556068 A3 EP4556068 A3 EP 4556068A3 EP 25169181 A EP25169181 A EP 25169181A EP 4556068 A3 EP4556068 A3 EP 4556068A3
Authority
EP
European Patent Office
Prior art keywords
nasal
benzodiazepines
orally inhaled
inhaled
orally
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP25169181.2A
Other languages
English (en)
French (fr)
Other versions
EP4556068A2 (de
Inventor
Karl-Uwe Petersen
Derek Jo Sakata
Thomas STÖHR
John Graham
Brett Cooper
Tatjana BEVANS
Christopher Reilly
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Paion UK Ltd
Original Assignee
Paion UK Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Paion UK Ltd filed Critical Paion UK Ltd
Publication of EP4556068A2 publication Critical patent/EP4556068A2/de
Publication of EP4556068A3 publication Critical patent/EP4556068A3/de
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Otolaryngology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Anesthesiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP25169181.2A 2016-04-14 2017-04-18 Oral inhalierte und nasale benzodiazepine Pending EP4556068A3 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
LU93027 2016-04-14
PCT/EP2017/059214 WO2017178663A1 (en) 2016-04-14 2017-04-18 Orally inhaled and nasal benzodiazepines
EP17721067.1A EP3442539B1 (de) 2016-04-14 2017-04-18 Oral inhalierte und nasale benzodiazepine

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP17721067.1A Division EP3442539B1 (de) 2016-04-14 2017-04-18 Oral inhalierte und nasale benzodiazepine

Publications (2)

Publication Number Publication Date
EP4556068A2 EP4556068A2 (de) 2025-05-21
EP4556068A3 true EP4556068A3 (de) 2025-07-23

Family

ID=55949007

Family Applications (2)

Application Number Title Priority Date Filing Date
EP17721067.1A Active EP3442539B1 (de) 2016-04-14 2017-04-18 Oral inhalierte und nasale benzodiazepine
EP25169181.2A Pending EP4556068A3 (de) 2016-04-14 2017-04-18 Oral inhalierte und nasale benzodiazepine

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP17721067.1A Active EP3442539B1 (de) 2016-04-14 2017-04-18 Oral inhalierte und nasale benzodiazepine

Country Status (13)

Country Link
US (4) US20190175613A1 (de)
EP (2) EP3442539B1 (de)
JP (2) JP2019513796A (de)
KR (1) KR20180131617A (de)
CN (1) CN109641000A (de)
AU (1) AU2017248683A1 (de)
BR (1) BR112018071082A2 (de)
CA (1) CA3020722A1 (de)
EA (1) EA036520B1 (de)
ES (1) ES3027652T3 (de)
IL (1) IL262087B (de)
MX (1) MX2018012498A (de)
WO (1) WO2017178663A1 (de)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111346098B (zh) * 2018-12-21 2022-05-27 宜昌人福药业有限责任公司 苯二氮䓬类化合物局部用药物组合物及制备方法和用途
CN111346065B (zh) * 2018-12-21 2022-05-20 宜昌人福药业有限责任公司 苯二氮䓬类化合物口腔用固体药物组合物及其制备方法
CN111346058B (zh) * 2018-12-21 2022-05-17 宜昌人福药业有限责任公司 一种苯二氮䓬类化合物经鼻粘膜给药的药物组合物及其制备方法和用途
EP3714884A1 (de) 2019-03-27 2020-09-30 Paion UK Limited Medizinische verwendung von benzodiazepinen mit einem bestimmten eeg-muster
CN112209932B (zh) * 2019-07-12 2023-03-24 成都倍特药业股份有限公司 一种化合物氢溴酸盐的新固体形态及其制备方法和用途
CN112462015B (zh) * 2020-11-18 2022-07-12 海南倍特药业有限公司 一种氢溴酸瑞马唑仑细菌内毒素的检测方法
CN112402428B (zh) * 2020-11-26 2022-02-25 李依泽 瑞马唑仑在制备治疗阿片类药物诱发的术后痛觉过敏的药物中的应用
CN114588164B (zh) * 2022-04-19 2023-08-11 天津医科大学总医院 瑞马唑仑在预防围术期低体温和寒战中的应用
CN120302962A (zh) * 2022-12-16 2025-07-11 Lts罗曼治疗系统股份公司 含有瑞马唑仑的口腔粘膜递送系统
CN121969363A (zh) * 2023-08-11 2026-05-01 Paion英国有限公司 瑞马唑仑用于儿科镇静的用途
WO2025052259A1 (en) * 2023-09-05 2025-03-13 Reena Patel Ready to use compositions of remimazolam
WO2026012465A1 (zh) * 2024-07-11 2026-01-15 宜昌人福药业有限责任公司 苯并二氮䓬类化合物、药物组合物及其用途

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US4950664A (en) * 1988-09-16 1990-08-21 Rugby-Darby Group Companies, Inc. Nasal administration of benzodiazepine hypnotics
CA2143246C (en) 1994-03-16 2000-08-22 Thierry Godel Imidazodiazepines
CN1168140A (zh) 1995-01-06 1997-12-17 弗·哈夫曼-拉罗切有限公司 羟甲基咪唑并二氮杂䓬及其酯
AU4382896A (en) 1995-02-02 1996-08-21 F. Hoffmann-La Roche Ag Acetylimidazobenzodiazepines
GB9911152D0 (en) 1999-05-14 1999-07-14 Glaxo Group Ltd Short-acting benzodiazepines
US7160880B1 (en) * 1999-05-14 2007-01-09 Cenes Limited Short-acting benzodiazepines
BRPI0714886B8 (pt) * 2006-07-10 2021-05-25 Paion Uk Ltd sais de benzodiazepina, seus usos e seus processos de preparação, e composição farmacêutica
GB0613693D0 (en) 2006-07-10 2006-08-16 Cenes Ltd Benzodiazepine salts (3)
GB0613692D0 (en) * 2006-07-10 2006-08-16 Cenes Ltd Benzodiazepine salts
GB0716907D0 (en) * 2007-08-31 2007-10-10 Archimedes Dev Ltd Pharmaceutical powder compositions
EP2305647A1 (de) * 2009-09-18 2011-04-06 PAION UK Limited Verfahren zur Herstellung von 3-[(4S)-8-brom-1-methyl-6-(2-pyridinyl)-4 H-imidazo[1,2-a][1,4]benzodiazepin-4-yl]propionsäuremethylester oder das Benzensulfonatsalz davon und in diesem Prozess nützliche Verbindungen
EP2450039A1 (de) * 2010-11-08 2012-05-09 PAION UK Ltd. Dosierschema zur Sedierung mit CNS 7056 (Remimazolam)
US20130309306A1 (en) 2010-12-01 2013-11-21 The Regents Of The University Of California Intrapulmonary benzodiazepine for the treatment and prevention of seizures
EP2694076A4 (de) * 2011-04-01 2014-08-27 Cpex Pharmaceuticals Inc Nasalformulierungen aus benzodiazepin
CN102964349A (zh) 2011-08-31 2013-03-13 江苏恒瑞医药股份有限公司 苯并二氮杂*衍生物的托西酸盐及其多晶型、它们的制备方法和用途
GEAP201813666A (en) * 2012-05-22 2018-01-25 Paion Uk Ltd Compositions comprising short-acting benzodiazepines
AU2013309860B2 (en) * 2012-08-31 2017-12-21 Paion Uk Limited Method for administering hypnotic/sedative agent
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CN103232454A (zh) * 2013-05-05 2013-08-07 王元青 治疗精神疾病的药物
CN107198691A (zh) * 2016-03-17 2017-09-26 江苏恒瑞医药股份有限公司 一种瑞马唑仑的药物组合物

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Title
PAMBIANCO DANIEL J ET AL: "New horizons for sedation: The ultrashort acting benzodiazepine remimazolam", TECHNIQUES IN GASTROINTESTINAL ENDOSCOPY, W.B. SAUNDERS, AMSTERDAM, NL, vol. 18, no. 1, 17 February 2016 (2016-02-17), pages 22 - 28, XP029553544, ISSN: 1096-2883, DOI: 10.1016/J.TGIE.2016.02.004 *
ZHOU YING ET AL: "Simultaneous determination of remimazolam and its carboxylic acid metabolite in human plasma using ultra-performance liquid chromatography-tandem mass spectrom", JOURNAL OF CHROMATOGRAPHY B, ELSEVIER, AMSTERDAM, NL, vol. 976, 2 December 2014 (2014-12-02), pages 78 - 83, XP029125542, ISSN: 1570-0232, DOI: 10.1016/J.JCHROMB.2014.11.022 *

Also Published As

Publication number Publication date
EP3442539B1 (de) 2025-04-09
ES3027652T3 (en) 2025-06-16
IL262087B (en) 2021-09-30
WO2017178663A1 (en) 2017-10-19
US20220273672A1 (en) 2022-09-01
IL262087A (en) 2018-11-29
US20260027128A1 (en) 2026-01-29
US20190175613A1 (en) 2019-06-13
EA201892327A1 (ru) 2019-04-30
AU2017248683A1 (en) 2018-10-25
JP2021185170A (ja) 2021-12-09
EP3442539C0 (de) 2025-04-09
MX2018012498A (es) 2019-07-01
EA036520B1 (ru) 2020-11-19
KR20180131617A (ko) 2018-12-10
US20200253983A1 (en) 2020-08-13
CN109641000A (zh) 2019-04-16
EP3442539A1 (de) 2019-02-20
CA3020722A1 (en) 2017-10-19
BR112018071082A2 (pt) 2019-02-05
EP4556068A2 (de) 2025-05-21
JP2019513796A (ja) 2019-05-30

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